The parenteral administration of medications, vitamins, pharmaceuticals, fluids, and the like are among the common medical, therapeutic or similar health or lifestyle interventions with an approximated more than one million infusions daily in the United States. Among the substances that are often administered intravenously, for example, are chemotherapeutic agents, antibiotics, anesthetics, blood and blood components, vitamins, minerals, fluids (such as blood plasma, saline solution, and the like) and total parenteral nutrition (TPN). Chemotherapeutic agents may also be administered by the intrathecal route. When administering a substance by the parenteral route, critical factors affecting safety and efficacy include the proper identification of the substance (such as a drug, a pharmaceutical composition, blood, a blood product, a blood component, plasma, a plasma derivative, a biological substance, total parenteral nutrition or the like), the dose, the rate, timing and route of administration and the like. Errors in these parameters or worse—the administration of parenteral drugs to the wrong patient—will often cause serious side effects, including in some cases, death.
In its landmark 1999 report—To Err is Human: Building a Safer Health System by Kohn L T, Corrigan J M, Donaldson M S, eds. National Academy Press, Washington, D.C., incorporated herein by reference, the United States Institute of Medicine indicated that medical errors currently result in more than 50,000 deaths annually, making it the 8th leading of cause of death in the United States, greater than motor vehicle accidents, breast cancer and AIDS. The overall cost of such medical errors was estimated to be between $17-29 billion per year. Sixty-one (61%) of the most serious and life-threatening potential adverse effects were related to the intravenous administration of drugs. Thus, errors in intravenous drug administrations were common, and were reported to occur in nearly 50% of instances of intravenous administrations; approximately 1% of these errors were considered potentially severe (Taxis K, Barber N. Ethnographic study of incidence and severity of intravenous drug errors. Brit J Med 326:684, 2003). Similarly, in pediatric inpatients intravenous (IV) medication errors accounted for up to 54% of adverse drug events (Kaushal R, Bates D W, Landrigan C, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA 285:2114-2120, 2001). The majority of these noted errors occurred at the times of the intravenous administration, and virtually all were reportedly due to human error.
Blood transfusion is a more complex endeavor than the usual intravenous drug infusion because a patient's blood sample must be provided for blood typing before the substance (blood or blood components) is administered. Errors have been found to be frequent in blood transfusion (Sazama K. Reports of 355 transfusion-associated deaths” 1976-1985. Transfusion 30:583-590, 1990, incorporated herein by reference). Thus, in one ongoing surveillance study in the transfusion arena—The Serious Hazards of Transfusion (SHOT) study, Serious Hazards of Transfusion (SHOT), Annual Report, 2003, incorporated herein by reference, which was implemented in the UK between the years 1996-2003, more than 66% of all serious hazards resulted from incorrect blood component administration (1,451 events out of 2,191 serious incidents reported) (Serious Hazards of Transfusion (SHOT), Annual Report, 2003, incorporated herein by reference). In another study Linden J V, Wagner K, Voytovich A E, Sheehan J. Transfusion errors in New York State: an analysis of 10 years' experience. Transfusion 40:1207-1213, 2000, incorporated herein by reference, which reviews transfusion errors in New York State over a 10-year period, it was found that the erroneous administration of blood occurred in 1/14,000 transfusion. With approximately 12 million blood transfusions reportedly administered in the United States annually, this extrapolates to nearly a thousand estimated erroneous transfusions annually in the United States alone. In that study, about 50% of errors occurred outside the blood bank, usually at the patient's bedside, and more than 90% were caused by human mistakes (such as administration of unit(s) of blood to the wrong patient).